Kentucky Administrative Regulations
Title 201 - GENERAL GOVERNMENT CABINET
Chapter 16 - Board of Veterinary Examiners
Section 201 KAR 16:600 - Prescription and dispensation of drugs for animal use
Universal Citation: 201 KY Admin Regs Service 16:600
Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS 258.015, 321.181(5)(b)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 321.181(5)(b) provides that the practice of veterinary medicine includes the prescribing, administering, or dispensing of drugs and medications for veterinary purposes. KRS 321.235(3) and 321.240(5) authorize the Kentucky Board of Veterinary Examiners to promulgate administrative regulations to carry out and enforce the provisions of KRS Chapter 321. This administrative regulation establishes a procedure for the prescription and dispensation of drugs by licensed veterinarians for use in animals.
Section 1. Definitions.
(1) "Legend drug" means a veterinary
prescription drug.
(2)
"Prescription" means an order from a veterinarian to a pharmacist or another
veterinarian authorizing the dispensing of a veterinary prescription drug to a
client for use on or in a patient.
(3) "Veterinary drug" means:
(a) A drug for animal use recognized in the
official United States Pharmacopoeia or official National Formulary of the
United States;
(b) A drug intended
for use in the diagnosis, cure, mitigation, treatment, or prevention of disease
in animals;
(c) A drug, other than
feed, medicated feed, or a growth promoting implant intended to affect the
structure or function of the body of an animal; or
(d) A drug intended for use as a component of
a drug in paragraph (a), (b), or (c) of this subsection.
(4) "Veterinary prescription drug" means:
(a) A drug that is not safe for animal use
without a veterinarian using or ordering the use of the product, and that is
required by federal law to bear the following statement: "Caution: federal law
restricts this drug to use by or on the order of a licensed
veterinarian";
(b) A drug that is
required by state law to be dispensed only on order or prescription of a
licensed veterinarian;
(c) The
extra-label use of an over-the-counter animal drug or human drug; and
(d) A medicament compounded by mixing two (2)
or more legally-obtained over-the-counter or prescription drugs.
Section 2. Prescribing and Dispensing.
(1) A veterinary prescription
shall include all of the following:
(a) The
name and address of the veterinarian and, if the prescription is a written
order, the signature of the veterinarian;
(b) The name and address of the
client;
(c) The species and
identity of the patient for which the prescription is issued;
(d) The name, strength, and quantity of the
drug prescribed;
(e) The date on
which the prescription is issued;
(f) The directions for administering the
drug;
(g) If the patient is a food
producing animal, the withdrawal time for the veterinary drug;
(h) If the prescription authorizes
extra-label use, the manner in which the client may use the drug;
(i) Any cautionary statements required by
law; and
(j) Number of refills
allowed, not to exceed the limitations established in Section 6(2) of this
administrative regulation.
(2) A veterinarian shall not prescribe for or
dispense to a client a veterinary prescription drug or a drug for extra-label
use without first personally examining the patient unless a
veterinarian-client-patient relationship (VCPR) already exists between the
prescribing veterinarian, client and patient, and the veterinarian determines
that the client has sufficient knowledge to administer the drug
properly.
(3) A veterinarian shall
not prescribe or dispense a veterinary prescription drug to a client unless the
veterinarian indicates in the appropriate records described in Section 4 of
this administrative regulation, within seventy-two (72) hours after the
prescription is issued or the drug is dispensed, that the prescription has been
issued or that the drug has been dispensed.
(4) A veterinarian shall not prescribe a drug
to a client for extra-label use on a patient unless all of the following apply:
(a) The VCPR exists between the veterinarian,
client and patient, and the veterinarian has made a careful medical diagnosis
of the condition of the patient within the context of that VCPR;
(b) The veterinarian determines that there is
no drug that is marketed specifically to treat the patient's diagnosed
condition, or determines that all of the drugs that are marketed for that
purpose are clinically ineffective;
(c) The veterinarian recommends procedures to
ensure that the identity of the patient receiving the drug can be readily
ascertained in the future; and
(d)
If the patient is a food producing animal, the veterinarian prescribes a
sufficient time period for drug withdrawal before the food from the patient may
be marketed.
(5) A
veterinarian shall not transmit a prescription electronically unless the client
approves the transmission and the prescription is transmitted to a pharmacist
or veterinarian designated by the client.
(6) A veterinarian shall not refuse to write
an otherwise appropriate prescription for a patient with a valid VCPR solely
because the prescription may be filled at an establishment other than the
veterinarian's own clinic or pharmacy.
Section 3. Labeling.
(1) A veterinarian shall not dispense a drug
that has been prepared, mixed, formulated, or packaged by the veterinarian
unless the veterinarian affixes to the container in which the drug is dispensed
a label containing all of the information specified in Section 2(1) of this
administrative regulation, except the address of the client.
(2) A veterinarian shall not dispense a
veterinary prescription drug that has been prepackaged by its manufacturer for
dispensing unless the veterinarian affixes to the container in which the drug
is dispensed a label containing all of the information specified in Section
2(1) of this administrative regulation, except the address of the
client.
(3) A veterinarian may
dispense a veterinary over-the-counter drug without affixing any information to
the container in which the drug is dispensed if a label that has been affixed
to the container by its manufacturer provides adequate information for its
use.
Section 4. Prescription Records.
(1) A veterinarian
shall maintain complete records of each veterinary prescription drug that the
veterinarian receives, prescribes, dispenses, or administers, and of each
prescription issued by the veterinarian that authorizes extra-label
use.
(2) Records of each veterinary
prescription drug shall include:
(a) The name
of each veterinary prescription drug that is received;
(b) The name and address of the person from
whom the drug is received;
(c) The
date and quantity received;
(d) The
name and address of the person to whom the drug is dispensed;
(e) The date and quantity dispensed;
and
(f) If the veterinarian
prescribes or administers the drug, the information specified in Section 2(1)
of this administrative regulation.
(3) Records of each prescription authorizing
extra-label use shall include the information specified in Section 2(1) of this
administrative regulation.
(4) A
veterinarian shall maintain records of each veterinary prescription drug for at
least five (5) years after the date on which the veterinarian prescribes,
dispenses, or administers the drug or extra-label use.
Section 5.
(1) A veterinarian may refuse to write a
prescription for controlled substances or a prescription for any medication
that, in the veterinarian's medical judgment, is not appropriate for the
patient's medical care.
(2) A
veterinarian may refuse to write a prescription if it is not directly requested
by a client with whom there is, in the veterinarian's opinion, a current and
existing VCPR.
(3) A prescription
shall be construed to include any manner of authorization for filling a
prescription, including verbal or electronic communication.
(4) The veterinarian may delegate to an
office employee the authority to communicate a refill of a legend drug to the
pharmacy on behalf of the veterinarian pursuant to written protocol established
prior to the delegation of that authority.
Section 6.
(1) A veterinarian shall ensure that federal
legend drugs and veterinary prescription drugs are maintained, logged,
administered, prescribed, dispensed, and destroyed in compliance with state and
federal laws.
(2) A veterinarian
shall not prescribe or dispense a quantity of drug that is greater than that
the amount required for one (1) year of treatment for an animal, herd, or
flock.
(3) To prescribe, sell,
distribute, or dispense any drug requiring a prescription for use in the
context of an animal, herd, or flock, a veterinarian shall first do all of the
following:
(a) Perform an appropriate history
and physical examination;
(b) Make
a diagnosis based upon the history, physical examination, and pertinent
diagnostic and laboratory tests;
(c) Formulate a therapeutic plan, and discuss
it with the animal's owner (or the owner's agent), along with the basis for it
and the risks and benefits of various treatments options, a part of which might
be a prescription drug; and
(d)
Ensure availability of the veterinarian or the veterinarian's staff for
appropriate follow-up care.
Section 7. Rabies Vaccine Administration. The administration of a rabies vaccine shall be in accordance with the provisions of KRS 258.015 and 902 KAR 2:070.
Section 8.
(1) A veterinarian may dispense a
prescription drug only if the prescribing veterinarian has established a
VCPR.
(2) If the dispensing
veterinarian does not have a VCPR, a licensed veterinary technician or a
veterinary assistant may assist in the delivery of a veterinary drug, legend
drug, or veterinary prescription drug only while he or she is under the direct
supervision of a licensed veterinarian.
(3) If the dispensing veterinarian does have
a VCPR, a licensed veterinary technician or veterinary assistant may assist in
the delivery of a veterinary drug, legend drug, or veterinary prescription drug
while he or she is under the indirect supervision of a licensed
veterinarian.
(4) If a licensed
veterinary technician or a veterinary assistant acts under the provisions of
this section, the licensed veterinarian shall ensure that the requirements of
this administrative regulation are met.
Section 9. Enforcement. If the board has reason to believe that a veterinarian or person claiming to be a veterinarian is violating or has violated this administrative regulation, the board may:
(1) Inspect the premises on which the
veterinarian or person claiming to be a veterinarian possesses, prescribes,
dispenses, labels or administers veterinary drugs;
(2) Inspect relevant records, equipment,
materials, containers, or facilities;
(3) Collect samples of veterinary drugs found
on the premises; and
(4) Conduct
any other investigative activities necessary to open a case and issue a
determination and, if necessary, hold hearings and enact discipline on the
individual.
STATUTORY AUTHORITY: KRS 321.235(3), 321.240(5)
Disclaimer: These regulations may not be the most recent version. Kentucky may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
